US FDA maintains market approval for key Genzyme drugs despite reports of steel and rubber fragments in some batches.
The contamination, found in less then 1 per cent of the products tested, affects lots of drugs labelled with the prefix “A”, including IV infusions of Cerezyme, Fabrazyme Myozyme, Aldurazyme as well as Thyrogen for intramuscular injection.
The Food and Drug Administration (FDA) said the foreign particles could "cause serious adverse events in patients," but added that "[it] is acutely aware of the critical need for patients to have continued access to these important products.
"In reaching its decision to allow these products to continue to be marketed, [the] FDA has carefully considered the potential for serious adverse events from foreign particle contamination," explaining the relatively low risk, coupled with the lack of alternative treatments, were the critical factors in its decision.
The agency also issued a set of guidelines designed to minimise the likelihood that contaminated products are used, ranging from greater use of visual inspection of vials to advocating enhanced patient monitoring.
For Genzyme the news is a further blow to its beleaguered production operations. In March, the FDA uncovered a number of deviations from current good manufacturing practice (cGMP) standards at the firm's facility in Allston, Massachusetts.
The FDA’s criticism was followed in June by Genzyme’s discovery of viral contamination at the facility, which temporarily halted production of Myozyme (alglucosidase alfa), Fabrazyme (agalsidase beta) and its biggest seller Cerezyme (imiglucerase).
Manufacturing at Allston restarted the end of July after an extensive cleaning effort, with shipment of products expected to begin later this month.
While it seems that the newly discovered contamination issue is unlikely to alter Genzyme’s shipment schedules, it is likely to increase pressure on the firm according to Oppenheimer & Co analyst Brian Abrahams
He told Reuters that: “This will likely raise regulatory scrutiny on a facility already under review.”
Genzyme spokesman Bo Piela said that the firm had not received reports of adverse events related to the presence of foreign particles and added that the risk of such contamination is present throughout the biotechnology sector.
Piela went on to say that the firm’s own inspections identify foreign bodies in around 1 per cent of its finished products, which, he said, is consistent with industry norms.